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Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO) (VIBRANT)

Primary Purpose

Branch Retinal Vein Occlusion

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Macular Laser Photocoagulation
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Branch Retinal Vein Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The following inclusion criteria include, but are not limited to:

  1. Adults ≥ 18 years of age with foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months before the screening visit
  2. ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening and at day 1
  3. Provide signed informed consent

Exclusion Criteria:

The following exclusion criteria include, but are not limited to:

  1. Current bilateral manifestation of BRVO
  2. Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye
  3. Insufficient clearing of macular hemorrhage that would prevent the patient from receiving laser treatment safely on day 1 (patients that meet this criterion may be rescreened once the macular hemorrhage resolves)
  4. Uncontrolled diabetes mellitus (DM)
  5. Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye
  6. Use of periocular corticosteroids in the study eye within 3 months before day 1
  7. Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the fellow eye within 3 months before day 1
  8. Previous administration of systemic anti-angiogenic medications
  9. Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid photocoagulation in the study eye

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Macular Laser Photocoagulation Treatment (Control)

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4

Arm Description

Participants will receive macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants will receive treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.

Participants will receive 2 milligrams (mg) Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group may receive laser rescue at week 36.

Outcomes

Primary Outcome Measures

Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF
Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24. Last observation carried forward (LOCF) method was used to impute missing data.

Secondary Outcome Measures

Change From Baseline to Week 24 in BCVA Score - LOCF
Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24 - Last observation carried forward (LOCF) method was used to impute missing data.
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
CRT was evaluated at every visit from baseline through week 24 using spectral domain Optical Coherence Tomography (OCT).
Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.

Full Information

First Posted
January 26, 2012
Last Updated
November 5, 2014
Sponsor
Regeneron Pharmaceuticals
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01521559
Brief Title
Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO)
Acronym
VIBRANT
Official Title
A Double-Masked, Randomized, Active-Controlled Study of the Efficacy, Safety, and Tolerability of Intravitreal Administration of VEGF Trap-Eye (Intravitreal Aflibercept Injection [IAI]) in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase III, double-masked, randomized, active-controlled, parallel-group, 52-week study to assess the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary to BRVO.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Branch Retinal Vein Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Macular Laser Photocoagulation Treatment (Control)
Arm Type
Sham Comparator
Arm Description
Participants will receive macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants will receive treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
Arm Title
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
Arm Type
Experimental
Arm Description
Participants will receive 2 milligrams (mg) Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group may receive laser rescue at week 36.
Intervention Type
Procedure
Intervention Name(s)
Macular Laser Photocoagulation
Intervention Type
Drug
Intervention Name(s)
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)
Primary Outcome Measure Information:
Title
Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF
Description
Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24. Last observation carried forward (LOCF) method was used to impute missing data.
Time Frame
Baseline to week 24
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 24 in BCVA Score - LOCF
Description
Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24 - Last observation carried forward (LOCF) method was used to impute missing data.
Time Frame
Baseline to Week 24
Title
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
Description
CRT was evaluated at every visit from baseline through week 24 using spectral domain Optical Coherence Tomography (OCT).
Time Frame
Baseline to week 24
Title
Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF
Description
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.
Time Frame
Baseline to week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The following inclusion criteria include, but are not limited to: Adults ≥ 18 years of age with foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months before the screening visit ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening and at day 1 Provide signed informed consent Exclusion Criteria: The following exclusion criteria include, but are not limited to: Current bilateral manifestation of BRVO Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye Insufficient clearing of macular hemorrhage that would prevent the patient from receiving laser treatment safely on day 1 (patients that meet this criterion may be rescreened once the macular hemorrhage resolves) Uncontrolled diabetes mellitus (DM) Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye Use of periocular corticosteroids in the study eye within 3 months before day 1 Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the fellow eye within 3 months before day 1 Previous administration of systemic anti-angiogenic medications Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid photocoagulation in the study eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
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United States
City
Beverly Hills
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California
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United States
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La Jolla
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California
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United States
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Mountain View
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Palm Desert
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Sacramento
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Colorado Springs
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Colorado
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Fort Myers
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Miami
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Plantation
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Stuart
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Tampa
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Winter Haven
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Augusta
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Georgia
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Chicago
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Illinois
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United States
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Baltimore (2 locations)
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Maryland
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United States
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Hagerstown
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Maryland
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United States
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Boston (2 locations)
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Massachusetts
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Grand Rapids
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Michigan
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United States
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Jackson
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United States
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Southfield
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Florissant
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Missouri
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Lincoln
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Nebraska
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United States
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Las Vegas
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Nevada
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United States
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Teaneck
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New Jersey
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United States
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Orchard Park
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New York
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United States
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Syracuse
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New York
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Charlotte
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North Carolina
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Oklahoma City
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Oklahoma
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Portland
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Oregon
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Kingston
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Pennsylvania
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West Mifflin
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Pennsylvania
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Florence
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South Carolina
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United States
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Ladson
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South Carolina
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West Columbia
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South Carolina
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Rapid City
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South Dakota
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United States
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Nashville
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Tennessee
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United States
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Abilene
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Texas
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United States
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Ft. Worth
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Texas
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United States
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Harlingen
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United States
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Houston
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San Antonio
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Seattle
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Washington
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Milwaukee
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Wisconsin
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Vancouver
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British Columbia
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Canada
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Victoria
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British Columbia
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Canada
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Mississauga
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Ontario
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Canada
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Toronto
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Ontario
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Canada
City
Urayasu-shi
State/Province
Chiba
Country
Japan
City
Amagasaki
State/Province
Hyogo
Country
Japan
City
Kagoshima-shi
State/Province
Kagoshima
Country
Japan
City
Hamamatsu-shi
State/Province
Shizuoka
Country
Japan
City
Fukushima
Country
Japan
City
Kyoto
Country
Japan
City
Osaka
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32633861
Citation
Shalchi Z, Mahroo O, Bunce C, Mitry D. Anti-vascular endothelial growth factor for macular oedema secondary to branch retinal vein occlusion. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD009510. doi: 10.1002/14651858.CD009510.pub3.
Results Reference
derived

Learn more about this trial

Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO)

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